Emerging Opportunities in Controlled-Release Generic Drugs

Publication Date	August 2009
Publisher	Espicom
Product Type	Report
Pages	128
ISBN Number	978-1-85822-366-7
Product Code	ESP00578

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Summary

This new report identifies 30 controlled-release drugs valued at US$15 billion, many of which will be losing patent protection in the medium term.

From emerging specialist companies to established generic producers, alternative drug delivery technologies are increasingly being seen as a route to a competitive edge in the generics industry.

While controlled-release products have traditionally been developed towards the patent-expiry, companies are now beginning to look at controlled-release delivery earlier in the product life-cycle and, in some cases, are launching immediate- and controlled-release versions of new drugs to address the differing needs of patients.

A number of significant controlled-release drugs - some of them blockbusters - will lose patent protection in the medium term. This has led to increased interest from a range of companies vying for a share of the controlled-release generics market.

Fewer competitors, higher margins

It's an attractive area: due to the significant technical barriers to the development of controlled-release drugs, they will generally have fewer competitors in the marketplace and, therefore, will attract higher prices and greater revenue opportunities than the highly competitive instant-release formulations.

A US$15 billion sector

The controlled-release drugs reviewed in this report had combined sales of more than US$15 billion in 2008. While the majority of these have patent protection for the controlled-release formulation, the validity of these patents is often the subject of litigation, particularly in the US where companies frequently file Paragraph IV certifications under the Hatch-Waxman act. In some cases, these legal challenges result in agreements between generic companies and originators, allowing the limited introduction of generics some years prior to patent expiry.

Identify key product opportunities, patent status and the activities of companies competing across all delivery platforms in this rapidly-developing growth area with this new 125+ page report:

Assess the current position and future potential of 30 CR therapies in key therapy areas
Evaluate the activities of 13 companies active in the field
Review the sector's position in the context of the broader generic market

A case in point...

Wyeth's Effexor XR

One of the most hotly contested controlled-release drugs in recent years has been Wyeth's US$3 billion Effexor XR (venlafaxine). A number of companies have filed ANDAs with the FDA for generic versions of Effexor XR, prompting Wyeth to file patent litigation suits. As of July 2009, cases against six companies remain outstanding: Sandoz, Mylan, Wockhardt, Biovail, Torrent and Apotex. To date, Impax and Mylan have received tentative approval for their ANDAs for generic venlafaxine controlled-release capsules.

In addition, Osmotica has an FDA-approved NDA for a controlled-release tablet form of venlafaxine. Understandably, this also prompted Wyeth to file a patent infringement lawsuit. Under a 2008 agreement, however, Osmotica was granted a licence in exchange for paying Wyeth a royalty on sales. Litigation has also been settled with Impax, Lupin, Anchen Pharmaceuticals and Teva Pharmaceutical Industries; three of these companies will be free to introduce generics under licence in 2011, while Teva will be able to launch a generic in July 2010, assuming FDA approval.

A win-win situation?

Licence agreements offer potential benefits to both generic companies and the originator. For the latter, it is a way of limiting early generic competition and cushioning the blow of revenue erosion by demanding royalty payments. Generic companies benefit from early market entry with limited competition, enabling them to establish their position prior to the expiry of the final patent when potentially more competitors can gain market approval. In the case of Effexor XR, Wyeth's final patent is not due to expire until 2017, providing a handful of companies with several years of limited competition for the price of royalty payments on what could be significant revenue for this blockbuster product.

Expert Research And Commentary

Published in August 2009 as part of a major ongoing report series, the report has been written by senior Espicom analyst Karen Holmes. Her wide experience in analysing company and drug pipelines, especially in the generics area, gives her a unique insight on the commercial implications for companies and investors. Other reports in the series to date are:

Injectable Generic Drugs: Prospects & Opportunities to 2013 (July 2008)
Emerging Opportunities in Inhalation & Nasal Spray Generic Drugs 2008 (October 2008)

Content

Foreword
Executive Summary
Overview
- Leading Generic Markets
- Controlled-Release Delivery Technology
- Delivery Platforms
- Controlled-Release Drugs
- FDA Approved Generics
Cardiovascular
- Lescol XL (fluvastatin)
- Patents & Exclusivity
- Generic Company Activity
- Advicor (lovastatin+niacin)
- Patents
- Generic Company Activity
- Coreg CR (carvedilol phosphate)
- Patents & Exclusivity
- Generic Company Activity
- Cardizem LA (diltiazem)
- Patents
- Generic Company Activity
- Seloken/Toprol-XL (metoprolol succinate)
- Generics
- Orbus Pharma
- Adalat CC (nifedipine)
- Patents
- Generic Company Activity
- Tarka (trandolapril+verapamil)
- Patents
- Generic Company Activity
- Aggrenox (dypyridamole+acetylsalicylic acid)
- Patents
- Generic Company Activity
CNS
- Concerta (methylphenidate)
- Patents
- Generic Company Activity
- Andrx (Watson)
- Impax
- Metadate CD / Equasym XL (methylphenidate)
- Patents
- Generic Company Activity
- Ritalin LA (methylphenidate)
- Patents
- Generic Company Activity
- Focalin XR (dexmethylphenidate)
- Patents
- Generic Company Activity
- Adderall XR (mixed amphetamine salts)
- Patents
- Generic Company Activity
- Barr & Teva
- Impax
- Actavis & Colony Pharmaceuticals
- Sandoz
- Andrx
- Carbatrol (carbamazepine)
- Patents
- Generic Company Activity
- Impax
- Nostrum
- CorePharma
- Teva
- Apotex
- Actavis
- Equetro (carbamazepine)
- Patents
- Generic Company Activity
- Tegretol XR (carbamazepine)
- Patents
- Generic Company Activity
- Seroquel XR (quetiapine)
- Patents & Exclusivity
- Generic Company Activity
- Amrix (cyclobenzaprine)
- Patents & Exclusivity
- Generic Company Activity
- Avinza (morphine)
- Patents
- Generic Company Activity
- OxyContin (oxycodone)
- Patents
- Generic Company Activity
- KV Pharmaceutical Company
- Mallinckrodt
- Impax Laboratories
- Teva Pharmaceutical Industries
- Endo Pharmaceuticals
- Opana ER (oxymorphone)
- Patents
- Generic Company Activity
- Impax
- Actavis
- Barr (Teva)
- Ultram ER (tramadol)
- Patents
- Generic Company Activity
- Cipher Pharmaceuticals
- Impax
- Effexor XR (venlafaxine)
- Patents
- Generic Company Activity
- Osmotica
- Lupin
- Cadila Healthcare
- Torrent Pharmaceuticals
- Sun Pharma
- Anchen Pharmaceuticals
- Mylan
- Apotex
- Biovail
- Impax
- Teva Pharmaceutical Industries
- Ambien CR (zolpidem tartrate)
- Patents
- Generic Company Activity
- Requip XL (ropinirole)
- Patents & Exclusivity
- Generic Company Activity
Others
- Xatral/Uroxatral (alfuzosin)
- Patents
- Generic Company Activity
- Oxytrol (oxybutynin)
- Patents
- Generic Company Activity
- Detrol LA (tolterodine)
- Patents
- Generic Company Activity
- Sanctura XR (trospium chloride)
- Patents & Exclusivity
- Generic Company Activity
- Augmentin XR (amoxicillin+clavulanic acid)
- Patents
Company Profiles
- Actavis
- CR/ER Products
- Patent Litigation & Agreements
- Oxymorphone litigation settled
- Acquisitions
- Actavis strengthens its position in India
- Actavis acquires Abrika
- Actavis acquires Alpharma's Human Generics business
- Financials
- Handa Pharmaceuticals
- Seroquel XR Litigation
- Impax Laboratories
- Products
- R&D
- Patent Litigation & Agreements
- Suit filed as Impax submits ANDA for generic Amrix
- Lawsuit for infringement of Renvela patents
- Lawsuit for infringement of Doryx patent
- Agreement with Teva
- Financials
- KV Pharmaceutical
- CR/ER Products
- Patent Litigation Agreement
- KV settles oxycodone litigation with Purdue Pharma
- Financials
- Mallinckrodt
- CR/ER Products
- Mylan
- Products
- Patent Litigation
- Amrix
- Effexor XR
- Uroxatral
- Acquisitions
- Merck Generics Acquisition
- Matrix Laboratories Acquisition
- Financials
- Par Pharmaceutical
- CR/ER Products
- Patent Litigation
- Par and Reliant settle propafenone litigation
- Litigation relating to tramadol extended-release tablets
- Agreements
- AstraZeneca/Par enter agreement for generic version of Toprol-XL
- IntelliPharmaCeutics announces equity investment by Par Pharmaceutical
- Agreement with Abrika (Actavis)
- Financials
- Sun Pharma
- CR/ER Products
- Financials
- Taro Pharmaceutical Industries
- CR/ER Products
- Financials
- Teva Pharmaceutical Industries
- Products
- Patent Litigation & Agreements
- Teva Launches Generic Adderall XR
- Watson files patent lawsuit against Barr for Oxytrol
- Aggrenox Litigation Settlement with Boehringer Ingelheim
- Barr and Kos Settle Advicor Patent Litigation
- Amrix Patent Infringement Lawsuit
- Focalin XR Patent Litigation
- Ritalin LA Patent Litigation
- OxyContin Settlement
- Effexor XR Agreement
- Major Developments
- Teva acquires Barr
- Financials
- URL Pharma
- CR/ER Products
- Watson Pharmaceuticals
- CR/ER Products
- Patent Litigation
- Watson files ANDA for generic Sanctura XR; Allergan files lawsuit
- Watson files Mucinex D ANDA; Reckitt Benckiser files lawsuit
- Watson files ANDA for generic Enablex; Novartis files lawsuit
- Andrx gains methylphenidate court victory
- Acquisition
- Watson completes acquisition of Andrx
- Financials
- Zydus Cadila
- CR/ER Products
- Financials
- Major Developments
- Etna Biotech Acquisition
- Majority stake in Simayla Pharmaceuticals
- Laboratorios Combix Acquisition
- SOURCES
- Espicom Sources
- Others
List of Tables
- Controlled-Release Drug Sales, 2008 (US$ Million)
- Controlled-Release Drugs by Therapy Area
- Controlled-Release Drugs by US Patent Expiry
- FDA ANDA Approval for Extended-Release Drugs, 2005-2009 (30th June)
- Lescol XL US Patents
- Advicor US Patents
- Coreg CR Sales, 2007-2008 (£ & US$ Million)
- Coreg CR US Patents
- Cardizem US Patents
- Seloken ZOK/Toprol-XL Sales, 2004-2008 (US$ Million)
- FDA ANDA Approvals for Metoprolol Succinate
- Adalat CC Sales, 2004-2008 (EUR & US$ Million)
- Adalat CC US Patents
- FDA ANDA Approvals for Nifedipine Extended-Release Tablets
- Tarka US Patents
- Aggrenox Sales, 2004-2008 (EUR & US$ Million)
- Aggrenox US Patents
- Concerta US Patents
- Metadate CD US Patents
- Ritalin LA US Patents
- Focalin XR US Patents
- Adderall XR US Patents
- Carbatrol US Patents
- Equetra US Patents
- Tegretol US Patent
- Seroquel XR US Patents
- Amrix US Patents
- Avinza US Patent
- OxyContin US Patents
- Opana ER US Patents
- Ultram ER US Patents
- Effexor XR US Patents
- Ambien CR US Patent
- Requip XL Sales, 2008 (£ & US$ Million)
- Requip XL US Patents
- Xatral/Uroxatral Sales, 2004-2008 (EUR & US$ Million)
- Uroxatral US Patents
- Tentative ANDA Approvals for 10mg Alfuzosin Hydrochloride ER Tablets
- Oxytrol US Patents
- Detrol LA US Patents
- Sanctura Sales, 2007-2008 (US$ Million)
- Sanctura XR US Patents
- Augmentin XR US Patents
- Actavis ANDA Approvals for CR/ER Products, 2006-2009
- Actavis Financial Results, 2003-2006 (EUR & US$ Million)
- Impax Laboratories ANDA Approvals for ER Products, 2004-2009
- Impax Financial Results, 2004-2008 (US$ Million)
- KV Pharmaceutical ANDA Approvals for CR/ER Products, 2004-2009
- KV Pharmaceutical Financial Results, 2004-2008 (US$ Million)
- Mallinckrodt ANDA Approvals for CR/ER Products, 2003-2009
- Mylan ANDA Approvals for CR/ER Products, 2002-2009
- Mylan Financial Results, 2004-2008 (US$ Million)
- Par Pharmaceutical Financial Results 2004-08 (US$ Million)
- Sun Pharma ANDA Approvals for CR/ER Products
- Sun Pharma: Financial Results, 2004-2008
- Taro ANDA Approvals for CR/ER Products
- Taro Pharmaceutical Industries restatements for 2004 and 2005 (US$000s)
- Teva ANDA Approvals for CR/ER Products, 2002-2009
- Barr ANDA Approvals for CR/ER Products, 2002-2009
- Teva Financial Results, 2004-2008 (US$ Millions)
- URL Pharma ANDA Approvals for ER Products, 2004-2009
- Watson ANDA Approvals for CR/ER Products, 2002-2009
- Andrx ANDA Approvals for CR/ER Products, 2002-2009
- Watson Financial Results, 2004-2008 (US$ Million)
- Zydus ANDA Approvals for CR/ER Products, 2005-2009
- Zydus Tentative ANDA Approval for CR/ER Product
- Zydus Cadila Financial Results, 2005-2009
List of Figures
- Generic Pharmaceutical Expenditure, 2008 (US$ Billions)
- Generic Pharmaceutical Expenditure per capita, 2008 (US$)
- Generic Pharmaceutical Expenditure as % of Total, 2008
- FDA ANDA Approvals by Therapy Area 2005-2009
- FDA ANDA Approvals by Therapy Area 2005-2009 (%)
- FDA ANDA Approvals by Company, 2005-2009